Responsible for daily production of 2 lines and sustaining activities for 5 medical device RF ablation product codes. Experience includes:-Leadership of change plans for new processes, equipment and product sustaining changes-New equipment and fixture qualification-3D modeling and rapid prototyping of fixtures-Reduction of processing times through 5S and lean manufacturing initiatives-Execution of NCR actions and CAPAs on time

Managed validation and process improvement projects for medical device sharps containers and syringes. Experience included:-Execution of change development plans-Authoring IQ, OQ/PQ validation protocols and reports for injection mold tools-Authoring Process Development Plans-DOE for resolving production issues and process optimization-Authoring design Verification protocols and reports

Medical device containers and disposable testing for product verification. Involved in the procurement of test equipment and materials for testing. Experience includes:-Test fixture design and development using PTC CREO-Test fixture verification-Attribute data test setup per ISO standards with additional ability to collect variable data for characterization.-Variable data test setup design and development-TMV, protocol and reports for medical device verification-Training and preparing engineering technicians for testing-Instron test method creation and execution.

Worked full-time on a novel microvascular device project. Teamed with project developers during the verification and validation phase. Significantly contributed to the advancement of the project by owning and writing a variety of test protocols, designing and developing test fixtures, executing testing, and writing technical reports for V&V in preparation for DHF and FDA submissionAccomplishments:-Test Fixture Prototyping, Machining and Development-3D Printing with SLS, FDM, SLA-Planned Medical Device Verification and Validation-V&V protocol and reports in preparation for DHF and FDA submission-TMV protocol-Performed design verification testing activities-Traveled to client location for medical device testing support-Saved client time and money with root cause analysis-User Validation Report for summative study

Implemented supplier change planning for product material and component changes, to ensure that the device would continue to meet both user needs and design specifications. Collaborated with co-workers in various engineering disciplines to discuss changes and complete design control documentation.

Actively worked with production team to improve yields of intraocular lens implants. Executed experiments to identify root causes of production issues and innovated solutions to address open CAPAs. Designed and developed novel prototype manufacturing fixtures for solutions.